Early Access Program for ALXN1840 in Patients With Wilson Disease

  • STATUS
    Recruiting
  • sponsor
    Alexion Pharmaceuticals
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Updated on 2 August 2023
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Summary

This is an open-label, single-arm, multi-center EAP, designed to provide early access to ALXN1840 for eligible patients with WD.

Description

To provide access to ALXN1840 treatment, an investigational medicinal product (IMP) that has not yet been granted marketing authorization, to participants who complete Studies ALXN1840-WD-205, WTX101-301, or ALXN1840-WD-302, or other studies with ALXN1840 who, in the opinion of the Treating Physician, may benefit from continued treatment with ALXN1840, and who meet the eligibility criteria described in this protocol.

Details
Condition Wilson Disease
Age 3years or above
Treatment ALXN1840
Clinical Study IdentifierNCT05686564
SponsorAlexion Pharmaceuticals
Last Modified on2 August 2023

Eligibility

 Yes No Not Sure

Inclusion Criteria

≥ 3 years of age or older at the time of providing informed consent/assent and expressed desire to continue treatment with ALXN1840
Confirmed diagnosis of WD
Has completed one of the following ALXN1840 clinical studies
ALXN1840-WD-205
WTX101-301
ALXN1840-WD-302
Other ALXN1840 studies
In the Treating Physician's medical opinion, the potential benefits of treatment with
ALXN1840 outweigh the potential risks for the participant
Participant or legal representative provided informed consent/assent to be treated with ALXN1840 through this EAP
Female participants of childbearing potential and male participants must follow protocol-specified-contraception guidance

Exclusion Criteria

Eligible for and able to participate in an Alexion-sponsored study of ALXN1840
Unwilling or unable to comply with the Treating Physician's treatment plan related to this EAP for any reason
Has decompensated hepatic cirrhosis
Model for End-Stage Liver Disease (MELD) score > 13\
Modified Nazer Score > 7\
End-stage renal disease on dialysis (chronic kidney disease stage 5 [CKD 5]) or creatinine clearance < 30 mL/min
Known hypersensitivity to ALXN1840, ALXN1840 excipients, or any of the ingredients contained in ALXN1840
Women who are nursing or pregnant (or women who are planning to become pregnant during treatment with ALXN1840)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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